Mr. Casey (for himself
and Ms. Murkowski) introduced the
following bill; which was read twice and referred to the
Committee on Health, Education, Labor,
and Pensions

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to
prevent the abuse of dextromethorphan, and for other purposes.

1.

Short
title

This Act may be cited as
the Preventing Abuse of Cough
Treatments Act of 2013 or the PACT Act.

2.

Sales of
over-the-counter drugs containing dextromethorphan

(a)

Prohibited
act

Section 301 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at
the end the following:

(ccc)(1)(A)

Except as provided in
subparagraph (2), the sale or offering for sale of a drug containing
dex­tro­me­thor­phan to an individual under 18 years of age, including any such
sale using the Internet, provided the drug is not subject to section
503(b)(1).

(B)

If a person fails to request
identification from an individual under 18 years of age and sells a product
containing dextromethorphan to that individual, that person shall be deemed to
have known that the individual was under 18 years of age, unless from the
individual’s outward appearance the person making the sale would reasonably
presume the individual to be 25 years of age or older.

(C)

It shall be an affirmative defense to
an alleged violation of clause (A) that the person selling a product containing
dextromethorphan examined the purchaser's identification card and, based on
that examination, that person reasonably concluded that the identification was
valid and indicated that the purchaser was not less than 18 years of
age.

(2)(A)

This paragraph shall
not apply to any sale made pursuant to a validly issued prescription.

(B)

This paragraph shall not apply to the
sale or offering for sale of a drug containing dextromethorphan to an
individual under 18 years of age if such individual supplies proof at the time
of such sale that such individual is actively enrolled in the military and
presents a valid military identification card.

(3)

In this paragraph, the term
identification card mean an identification card that—

(A)

includes a photograph and the date of
birth of the individual; and

(B)

is issued by a State or the Federal
Government or is considered acceptable for purposes of sections
274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B)(1) of title 8, Code of Federal
Regulations (as in effect on or after the date of the enactment of the
Preventing Abuse of Cough Treatments Act of
2013).

.

(b)

Civil
penalties

Section 303 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 333) is amended by adding at the end the following:

(h)

Notwithstanding
subsection (a), the following provisions shall apply to violations of section
301(ccc):

(1)

A person who
violates section 301(ccc) shall—

(A)

receive a warning
letter from the Secretary for the first such violation; and

(B)

be subject to a
civil penalty in an amount—

(i)

not more than
$1,000 for the second such violation by a person;

(ii)

not more than
$2,000 for the third such violation by a person; and

(iii)

not more than
$5,000 for the fourth such violation, or a subsequent such violation, by a
person.

(2)

In determining
the amount of a civil penalty under this subsection for a person who is a
retailer, the Secretary shall consider whether the retailer has taken
appropriate steps to prevent subsequent violations, such as the establishment
and administration of a documented employee training program to ensure all
employees are familiar with and abiding by the provisions of section 301(ccc),
where such program includes—

(A)

educating
employees regarding products containing dextromethorphan;

(B)

instruction on
the correct method of checking a purchaser’s identification card; and

(C)

notifying
employees of the civil penalties under this subsection.

(3)

If a person who
is a retailer transacts sales of products containing dextromethorphan at more
than one physical location, for purposes of determining the number of
violations by that person under this subsection, each individual physical
location operated by that retailer shall be considered a separate
person.

(4)

The Secretary
shall notify persons found to have violated section 301(ccc) as soon as
practicable after the Secretary discovers such violation. Such notification
shall include details of the violation, such as—

(A)

the date and time
of the sale;

(B)

a sales receipt
or credit card receipt documenting the sale; and

(C)

the name or
description of the employee involved in the sale.

(5)

Notwithstanding
any other provision of this subsection or section 301(ccc), an employee shall
not be subject to penalties under this subsection unless such employee
knowingly and willfully participates in a conspiracy to violate section
301(ccc). For purposes of this paragraph, a conspiracy shall consist of an
agreement between two or more persons with the intent to violate section
301(ccc) and the commission of at least one overt act in furtherance of the
agreement.

(6)

In this
subsection—

(A)

the term employee means an
individual who is employed by a retailer in a clerical or other non-managerial
position; and

(B)

the term
retailer means a grocery store, general merchandise store, drug
store, pharmacy, convenience store, or other entity or person whose activities
as a distributor relating to products containing dextromethorphan are limited
almost exclusively to sales for personal use, both in number of sales and
volume of sales, either directly to walk-in customers or in face-to-face
transactions by direct
sales.

If it is
unfinished dextromethorphan and is possessed, received, or distributed in
violation of section 506G.

;

(2)

by inserting
after section 506F the following:

506G.

Restrictions
on the distribution of bulk dextromethorphan

(a)

In
general

No person shall—

(1)

possess or
receive unfinished dex­tro­me­thor­phan, unless the person is registered under
section 510 or otherwise registered, licensed, or approved pursuant to Federal
or State law to engage in the practice of pharmacy, pharmaceutical production,
or manufacture or distribution of drug ingredients; or

(2)

distribute
unfinished dextromethorphan to any person other than a person registered under
section 510 or otherwise registered, licensed, or approved pursuant to Federal
or State law to engage in the practice of pharmacy, pharmaceutical production,
or manufacture or distribution of drug ingredients.

(b)

Exception for
common carriers

This section does not apply to a common carrier
that possesses, receives, or distributes unfinished dextromethorphan for
purposes of distributing such unfinished dex­tro­me­thor­phan between persons
described in subsection (a) as registered, licensed, or approved.

(c)

Definitions

In
this section:

(1)

The term
common carrier means any person that holds itself out to the
general public as a provider for hire of the transportation by water, land, or
air of merchandise, whether or not the person actually operates the vessel,
vehicle, or aircraft by which the transportation is provided, between a port or
place and a port or place in the United States.

(2)

The term
unfinished dextromethorphan means dextromethorphan that is not
contained in a drug that is in finished dosage
form.

;
and

(3)

by amending
section 303, as amended by section 2(b), by adding at the end the
following:

(i)

Notwithstanding
subsection (a), a person who violates section 506G shall be subject to a civil
penalty of not more than
$100,000.